Interim Head of Nonclinical Development for Preclinical Biologics Biotech

Logistics Vice President Level 20 hours per week for 6 months Remote, ideally from US- East Coast or Central Time Zones Travel Requirements: Ability to visit HQ in Philadelphia, PA 1-3 times per quarter Hourly rate: $175 - $350 About Clora's client is a preclinical-stage biologics biotech company focused on advancing next-generation single administration therapies. The client is looking for an interim Head of Nonclinical Development consultant to own the design, execution, and regulatory strategy of the nonclinical program across the client's portfolio. This role is accountable for ensuring that IND-enabling pharmacology, DMPK, and GLP toxicology studies meet current regulatory expectations and are executed with high quality, speed, and discipline. The interim Head of Nonclinical Development will support the integrated nonclinical development plan, manages CRO partners, authors the nonclinical sections of regulatory submissions, and serves as the internal expert on nonclinical safety and regulatory strategy. Operating at both the strategic and execution level in a startup environment, this individual is equally comfortable shaping study concepts with the CSO, challenging a CRO protocol at the line-item level, interpreting a pathology finding, and defending study design choices in a Pre-IND meeting with FDA.

Responsibilities

• End-to-End Nonclinical Leadership: Owns and drives integrated nonclinical strategies across pharmacology, DMPK/ADME, biodistribution, safety pharmacology, and GLP toxicology to enable IND/CTA filings, first-in-human studies, and clinical progression.
• Regulatory Strategy & Execution: Leads nonclinical regulatory strategy in alignment with FDA, EMA, and ICH expectations. Oversees preparation of IND/CTA-enabling content (e.g., Pre-IND packages, Investigator Brochures) and authors responses to health authorities.
• External Partner Oversight: Selects and manages CROs and specialty labs; approves study designs, monitors execution, and ensures delivery against timelines, budgets, and quality standards.
• Scientific Accountability: Serves as sponsor lead for nonclinical studies; interprets pharmacology, toxicology, and toxicokinetic data; identifies risks; and delivers clear, defensible conclusions to inform development decisions.
• Cross-Functional Alignment: Partners with CMC, Translational, Clinical Development, and Regulatory teams to align nonclinical plans with manufacturing readiness, clinical design, and program milestones
• Operational Excellence: Builds and drives realistic, aggressive nonclinical timelines; anticipates bottlenecks; and makes pragmatic trade-offs across scope, cost, and risk to maintain momentum without compromising quality.
• Strategic Communication: Authors and reviews key nonclinical and regulatory documents with clarity and scientific rigor; represents the company in regulatory and external engagements.

Ideal Candidate

• 8–12+ years in biotech or pharmaceutical nonclinical development, with direct, hands-on accountability for IND-enabling programs that have successfully cleared FDA (or equivalent) review. Demonstrated track record of moving programs from candidate selection through IND and into first-in-human studies.
• Deep working knowledge of GLP toxicology, safety pharmacology, DMPK/ADME, and ICH/FDA nonclinical guidances. Strong preference for direct experience with gene therapy, AAV or other viral vectors, or other advanced therapy modalities, including familiarity with FDA CBER expectations, biodistribution and shedding studies, and integration/germline considerations.
• Proven ability to manage multiple CROs in parallel, hold vendors to high standards, and deliver studies on time and on budget. Comfortable getting into the details of protocols, SOPs, and raw data when it matters.
• Experience authoring nonclinical sections of INDs/CTAs and supporting meetings with FDA or equivalent authorities.
• Thrives as part of a small, fast-moving, mission-driven team. Brings urgency, ownership, and a bias toward decisions, while maintaining the discipline and scientific rigor that nonclinical work demands.
• PhD, DVM, PharmD, MD, or equivalent in toxicology, pharmacology, veterinary medicine, or a related discipline strongly preferred. DABT certification is a plus. Candidates with a Bachelor's or Master's degree and significant, directly relevant industry experience will also be considered.